# K142218: Coalition AGX Plate and Coalition AGX Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Mar 31, 2015 after 231 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K003155 (2001). 81 ancestors in all.
155 later devices descend from it; 9 cite it directly.
0 of 237 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130478: Sustain and Sustain Radiolucent Spacers, Globus Medical, Inc. (2013) Summary page 4.
- K081391: Vip Anterior Cervical Plate System, Globus Medical, Inc. (2008) Summary page 4.
- K092070: Interplate C, Rsb Spine, LLC (2009) Summary page 4.
- K122630: IN:C2 Spinal Fixation System, Spine Smith Partners L.P. (2012) Summary page 4.
- K073285: Peek Prevail Cervical Interbody Device, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 4.
- K072991: Patriot Spacers: Colonial Acdf, Globus Medical, Inc. (2008) Summary page 4.
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 4.

## Most influential descendants
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (2017), 149 descendants of its own
- K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers (2018), 97 descendants of its own
- K191391: HEDRON Lumbar Spacers (2019), 84 descendants of its own
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS (2017), 83 descendants of its own
- K192115: SABLE Expandable Spacer (2020), 37 descendants of its own

## Indications for use
The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The COALITION AGX™ Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-TI) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The COALITION AGX™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation such as the COALITION AGX™ Plate, ASSURE®, PROVIDENCE™, VIP®, XTEND®, or UNIFY™ Anterior Cervical Plate Systems. When used with the COALITION AGX™ Plate, the assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation.

Source page: https://510kreport.com/device/K142218
Methodology: https://510kreport.com/methodology